Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232564
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-12-14
Brief Title:
A Study of Etoposide-carboplatin in Combination With Pembrolizumab and Lenvatinib Maintenance in HG-NETs
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
PELICAN a Phase II Study of Etoposide-carboplatin Chemotherapy in Combination With Pembrolizumab and Lenvatinib Maintenance in Advanced High-grade Neuroendocrine Tumours HG-NETs
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PELICAN
Brief Summary:
This is an open label single arm phase II multicentre study designed to evaluate the efficacy and safety of pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy in patients with HG-NETs who are chemotherapy-naïve for their metastatic disease The study will be conducted in up to 10 sites and will recruit up to a maximum of 20 evaluable participants
Detailed Description:
This is an open label single arm phase II multicentre study designed to evaluate the efficacy and safety of pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy in patients with HG-NETs who are chemotherapy-naïve for their metastatic disease The study will be conducted in up to 10 sites and will recruit up to a maximum of 20 evaluable participants
Patients who satisfy study inclusion criteria will be offered the possibility of participating in the study A patient information sheet and a written consent form will be offered to every patient Informed consent must be obtained prior to initiation of any clinical screening procedure that is performed solely for the purpose of determining eligibility for research
Investigators must ensure that subjects are clearly and fully informed about the purpose of the study in which they volunteer to participate In situations where consent cannot be given to subjects their legally acceptable representatives are clearly and fully informed about the purpose the subject volunteers to participate The consent form which will include all elements required by ICH GCP and applicable regulatory and will adhere to the ethical principles that have their origin in the Declaration of Helsinki
Following written content investigators will assess
Patients Demographics and Medical History
Patients Eligibility Confirmation
The treatment schedule recognizes an induction phase and a maintenance phase
Induction Phase Following informed consent and screening investigations 28 days window patients will receive 4 cycles of induction chemotherapy with carboplatin AUC 5mgmlmin administered IV alongside etoposide 120 mgm2 and pembrolizumab 200 mg IV on day 1 of a 21-days cycle followed by oral etoposide 100 mg twice daily on day 2-3 of each cycle
Maintenance Phase In patients who achieve a complete partial response or stable disease following induction maintenance pembrolizumab 200 mg IV on day 1 every 21 days and lenvatinib 20 mg PO daily will start following completion of induction treatment and will continue until unacceptable toxicity disease progression withdrawal of consent or completion of 2 years of treatment In days when Lenvatinib is co-administered with pembrolizumab lenvatinib should be administered prior to pembrolizumab ideally in the morning of the study visit Re-staging by computerised tomography CT will be performed 21 days after completion of induction then 9-weekly until study completion A second optional tumour biopsy will be taken at C3 Day 1 - 14 days
Patients who satisfy study inclusion criteria will be offered the possibility of participating in the study A patient information sheet and a written consent form will be offered to every patient Informed consent must be obtained prior to initiation of any clinical screening procedure that is performed solely for the purpose of determining eligibility for research
Investigators must ensure that subjects are clearly and fully informed about the purpose of the study in which they volunteer to participate In situations where consent cannot be given to subjects their legally acceptable representatives are clearly and fully informed about the purpose the subject volunteers to participate The consent form which will include all elements required by ICH GCP and applicable regulatory and will adhere to the ethical principles that have their origin in the Declaration of Helsinki
Following written content investigators will assess
Patients Demographics and Medical History
Patients Eligibility Confirmation
The treatment schedule recognizes an induction phase and a maintenance phase
Induction Phase Following informed consent and screening investigations 28 days window patients will receive 4 cycles of induction chemotherapy with carboplatin AUC 5mgmlmin administered IV alongside etoposide 120 mgm2 and pembrolizumab 200 mg IV on day 1 of a 21-days cycle followed by oral etoposide 100 mg twice daily on day 2-3 of each cycle
Maintenance Phase In patients who achieve a complete partial response or stable disease following induction maintenance pembrolizumab 200 mg IV on day 1 every 21 days and lenvatinib 20 mg PO daily will start following completion of induction treatment and will continue until unacceptable toxicity disease progression withdrawal of consent or completion of 2 years of treatment In days when Lenvatinib is co-administered with pembrolizumab lenvatinib should be administered prior to pembrolizumab ideally in the morning of the study visit Re-staging by computerised tomography CT will be performed 21 days after completion of induction then 9-weekly until study completion A second optional tumour biopsy will be taken at C3 Day 1 - 14 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None